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This paper discusses the use in dental practices of quaternary ammonium compounds (QAC) and alcohol-based disinfectants in relation to bactericidal efficacy against mycobacteria. QAC disinfectants are commonly used in dental practices, although there are concerns about their efficacy against tuberculosis-causing bacteria. The paper discusses a recent study where two QAC products (readyto-use and saturated wipe liquor presentations) were tested, using a recognized suspension test, at the manufacturer's recommended concentration, under simulated 'clean' and 'dirty' conditions. The test data indicated that, after a 10-minute contact time, suitable kill of the test organism was not obtained. These findings raise questions about the suitability of QAC disinfectants for dental practices. CPD/Clinical Relevance: Tuberculosis, a disease caused by Mycobacterium tuberculosis, is increasingly becoming a communicable disease of concern. It is important that dental practices ensure that a suitable level of decontamination takes place between patients. QAC disinfectants may not be suitable for this purpose and alternative biocides, like alcohol, may need to be considered.


— Factors such as rising geriatric population and increasing number of hemophilic patients are boosting the market growth. However, strict government rules, huge cost and limited reimbursements are some of the factors hampering the market. Rising digit of Hemophilic Patients is creating growth opportunities for vendors in the market. By product, immunoglobulin segment dominated the global market with largest share in 2013 owing to growing geriatric population with neurological and autoimmune disease. By region, North America accounted for largest market share followed by Europe. However, Asia-Pacific is anticipated to grow at the highest CAGR owing to increasing digit of hemophilic patients and rising awareness of technologically advanced products in this region. Some of the key players in Plasma Fractionation market include Octapharma AG, Chinese Biological Products, Inc., Baxter International, Inc., Bio Products Laboratory, Grifols International SA, Shanghai Raas Blood Products Co., Ltd, Csl, Ltd., China Biologic Products, Inc., Kedrion S.P.A., Biotest, Sanquin and LFB SA. Regions Covered: • North America o US o Canada o Mexico • Europe o Germany o France o Italy o UK o Spain o Rest of Europe • Asia Pacific o Japan o China o India o Australia o New Zealand o Rest of Asia Pacific • Rest of the World o Middle East o Brazil o Argentina o South Africa o Egypt What our report offers: - Market share assessments for the regional and country level segments - Market share analysis of the top industry players - Strategic recommendations for the new entrants - Market forecasts for a minimum of 7 years of all the mentioned segments, sub segments and the regional markets - Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations) - Strategic recommendations in key business segments based on the market estimations - Competitive landscaping mapping the key common trends - Company profiling with detailed strategies, financials, and recent developments - Supply chain trends mapping the latest technological advancements About Stratistics MRC We offer wide spectrum of research and consulting services with in-depth knowledge of different industries. We are known for customized research services, consulting services and Full Time Equivalent (FTE) services in the research world. We explore the market trends and draw our insights with valid assessments and analytical views. We use advanced techniques and tools among the quantitative and qualitative methodologies to identify the market trends. Our research reports and publications are routed to help our clients to design their business models and enhance their business growth in the competitive market scenario. We have a strong team with hand-picked consultants including project managers, implementers, industry experts, researchers, research evaluators and analysts with years of experience in delivering the complex projects. For more information, please visit http://www.strategymrc.com/


News Article | December 16, 2016
Site: marketersmedia.com

— The report "Plasma Fractionation Market by Product (Albumin, Immunoglobulin, Factor VIII, Protease Inhibitors), Application (Neurology, Hematology, Rheumatology, Immunology) End User (Hospitals, Clinical Research Laboratories) - Global Forecast to 2021", The plasma fractionation market witnessed healthy growth during the last decade and is expected to grow at a CAGR of 6.7% between 2016 and 2021 to reach USD 26.07 Billion by 2021. Growth in this market can be attributed to factors such as rise in aging population worldwide, the increasing on and off-label use of immunoglobulin for various chronic diseases, increased diagnosis rate, and rise in the use of prophylactic treatment for bleeding and immune diseases. The global plasma fractionation market is segmented based on products, applications, end users, and regions. Based on products, the market is further segmented into immunoglobulin, coagulation factor concentrates, albumin, protease inhibitors, and other plasma products. Based on application types, the market is further segmented into neurology, immunology, hematology, pulmonology, hemato-oncology, rheumatology, critical care, and other applications. On the basis of end users, the global plasma fractionation market is segmented into hospitals and clinics, clinical research laboratories, and academic institutes. Based on regions, the plasma fractionation market is segmented into North America, Europe, Asia-Pacific, and the Rest of the World. In 2015, immunoglobulin accounted for the largest share of the global plasma fractionation market. However, the protease inhibitors segment is expected to witness the highest growth in the next five years. The growth of protease inhibitors is mainly attributed to its increasing use for respiratory diseases and growing application in various diseases. On the basis of applications, the neurology segment accounted for the largest share of the global plasma fractionation market. The large share of this market segment is mainly due to factors such as increasing use of immunoglobulin in neurological diseases. In the end-user segment, hospitals and clinics accounted for the largest share of the plasma fractionation market and are expected to grow at the highest CAGR in next five years. This large share is due to the increasing use of plasma products for labeled and off-labeled use for the treatment of various diseases in hospitals and clinics. North America is the largest regional segment for plasma fractionation. The large share of this regional segment can be attributed increasing use of immunoglobulins in neurological diseases and increasing use of prophylaxis treatments for diagnosed patients, and the rising number of registered hemophilic patients in this region. However, the market in the Asia-Pacific region is expected to grow at the highest CAGR, owing to the rapid growth in the aging population, increasing use of albumin and immunoglobulin, and increasing number of hemophilic patients. CSL Ltd. (Australia), Grifols S.A (Spain), Baxalta Incorporated (U.S.), Octapharma AG (Switzerland), and Kedrion S.p.A (Italy) held the major share of the plasma fractionation market and will continue to dominate the market between 2016 and 2021. Other major players operating in this market are Bio Products Laboratory (U.K.), Sanquin (Netherland), China Biologic Products, Inc. (China), Biotest AG (Germany), and Laboratoire Français du Fractionnement et des Biotechnologies (France). For more information, please visit http://www.marketsandmarkets.com/Market-Reports/plasma-fractionation-market-93798284.html


Sandle T.,Bio Products Laboratory
European Pharmaceutical Review | Year: 2016

Assessing microbial levels in, and on, samples is an important part of pharmaceutical process control. Samples are drawn from the intermediate product at defined stages (ideally based on risk assessment) and these allow for the microbial levels to be tracked from upstream processing to downstream processing (with an expectation that the microbial levels decrease, or at least remain unchanged provided they are below an acceptable action level). For aseptic products, European guidelines require a certain bioburden to be met at the point that a bulk product passes through a sterilising grade filter. Due to the relatively low specification - of 10 CFU/100mL - pharmaceutical manufacturers need to ensure that false positive results as might arise from extraneous environmental contamination are avoided. False positives can result in batch rejection. © 2016 Thermo Fisher Scientific Inc.


Vijayakumar R.,Majmaah University | Sandle T.,Bio Products Laboratory
European Pharmaceutical Review | Year: 2016

Endotoxin contamination in ophthalmic pharmaceuticals and medical devices presents a risk to users; moreover, endotoxins can cause acute inflammation of the eye following ocular lens replacement surgery. This article reviews the risks and requirements for product testing, together with current regulatory guidances. It further analyses recall data relating to ophthalmic pharmaceuticals due to endotoxin contamination. The article concludes by making recommendations for endotoxin control and sets out appropriate endotoxin test limits for finished ophthalmic products. He has a doctorate in microbiology from Bharathidasan University, India. He has over 14 years' experience in the ophthalmic pharmaceutical industry and microbiological research. He has written two books and published more than 15 research articles in peer-reviewed international journals. His current research work is on 'Biocides resistance mechanisms of environmental and clinical isolates'.


Sandle T.,Bio Products Laboratory
European Pharmaceutical Review | Year: 2014

Pharmaceutical manufacturing is subject to strict regulatory inspection. For this purpose, regulatory bodies issue guidance documents that draw on international standards, with many of these documents impacting on contamination control and assessment. This article surveys some of the recent developments in regulatory requirements and standards that have taken place during the past 12 months, highlighting those aspects that are of relevance to pharmaceutical microbiology. The review takes stock of pharmacopoeial changes and inspectorate guidelines and is divided into different sections based on the broad subject matter.


Sandle T.,Bio Products laboratory
BioPharm International | Year: 2012

Closures that form part of the container-closure system are an important component in the packaging of sterile products. Container-closures maintain the sterility of parenteral pharmaceuticals and prevent ingress of contamination when a needle is inserted into a vial. This article describes important aspects to consider in the manufacture of closures for pharmaceutical preparations, as well as the various physical, chemical, and biological assessments required to ensure that these closures are fit for purpose.


Sandle T.,Bio Products Laboratory
European Pharmaceutical Review | Year: 2015

The methods for monitoring air in cleanroom environments: viable counting techniques (settle plates and biological air samplers) and particle counters, are long established technologies and have been widely used in pharmaceutical manufacturing environments for decades. Although innovations have taken place with both particle counters and biological air samplers, primarily in relation to the size of the instruments and in reducing the time taken to collect a fixed volume of air, the essential technology has remained unchanged. However, recently, some new technologies for biological air sampling have been developed (bio-air systems), which will be discussed in this article. © 2015, Russell Publishing. All rights reserved.


Sandle T.,Bio Products Laboratory
GMP Review | Year: 2013

Although the FDA guidance is less comprehensive than the supporting chapter in the European Pharmacopoeia it provides an important indication of the Agency's thinking on the subject and, unlike the EP guidance, it includes topical subjects like Quality by Design. By adopting a Q&A format the FDA guidance is clear and straightforward to read and the questions posed generally cover most of those considered by laboratory staff tasked with carrying out he test and QA personnel who have a responsibility in releasing products subject to endotoxin testing.


Various chromatographic procedures are used during the purification and manufacture of plasma products such as coagulation factors. These steps contribute to the overall safety of such products by removing potential virus contamination. Virus removal by two affinity chromatography procedures, i.e. monoclonal antibody chromatography and metal chelate chromatography (immobilised metal ion affinity chromatography), used during the manufacture of the high purity factor VIII (Replenate®) and factor IX (Replenine®-VF), respectively, has been investigated. In addition, as these columns are recycled after use, the effectiveness of the sanitisation procedures for preventing possible cross-contamination, has also been investigated.Both chromatographic steps proved effective for eliminating a range of model enveloped and non-enveloped viruses by 4 to >6 and 5 to >8log for the monoclonal and metal chelate columns, respectively. The effectiveness of the relatively mild column sanitisation conditions used, i.e. ethanol for factor IX and acetic acid for factor VIII, was confirmed using non-spiked column runs. The chemicals used contributed to virus elimination by inactivation and/or by physical removal of the virus. In summary, these studies demonstrate that potential virus contamination between chromatographic runs can be prevented when an effective column recycling and sanitisation procedure is included. © 2014 The International Alliance for Biological Standardization.

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